biobank-repository/SOPs/Specimen-Collection/SOP-BIO-001-Specimen-Collection.md

# Standard Operating Procedure: Biological Specimen Collection

| Document ID | SOP-BIO-001 |
|-------------|-------------|
| Title | Biological Specimen Collection Procedure |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Biobank Operations |

---

## 1. Purpose

To establish standardized procedures for the collection, labeling, and initial processing of biological specimens to ensure sample integrity, proper chain of custody, and compliance with regulatory requirements.

## 2. Scope

This procedure applies to the collection of all biological specimens including:
- Blood and blood components
- Tissue samples (fresh and fixed)
- Body fluids (CSF, urine, synovial fluid)
- DNA/RNA samples
- Cell lines and derivatives
- FFPE blocks and slides

## 3. Responsibilities

### 3.1 Collection Personnel
- Follow aseptic technique during collection
- Complete all required labeling and documentation
- Ensure proper specimen handling post-collection

### 3.2 Biobank Coordinator
- Train collection personnel
- Verify specimen quality upon receipt
- Maintain collection supply inventory

### 3.3 Quality Manager
- Review collection metrics
- Investigate collection deviations
- Approve collection protocols

## 4. Definitions

| Term | Definition |
|------|------------|
| Aliquot | A portion of a specimen separated for individual storage/testing |
| Chain of Custody | Documented history of specimen handling and transfers |
| Cryopreservation | Preservation of specimens at ultra-low temperatures |
| FFPE | Formalin-Fixed Paraffin-Embedded tissue |

## 5. Equipment and Materials

- Collection tubes (type depends on specimen)
- Sterile containers and cryovials
- Labels (barcode and human-readable)
- Collection kits per specimen type
- PPE (gloves, gown, eye protection)
- Temperature monitoring devices
- Biohazard bags and containers

## 6. Procedure

### 6.1 Pre-Collection Preparation

1. **Verify Consent Status**
   - Confirm informed consent on file
   - Verify consent covers intended specimen use
   - Document consent verification

2. **Prepare Collection Materials**
   - Select appropriate collection containers
   - Pre-label containers with unique identifiers
   - Verify label accuracy against order
   - Prepare shipping/transport supplies if needed

3. **Verify Patient/Donor Identity**
   - Use two patient identifiers
   - Compare against order/consent
   - Document verification method

### 6.2 Specimen Collection

#### 6.2.1 Blood Collection
| Tube Type | Additive | Uses | Special Handling |
|-----------|----------|------|------------------|
| Red top | None (clot) | Serum | Allow to clot 30-60 min |
| Lavender | EDTA | Plasma, CBC, DNA | Invert 8-10 times |
| Green | Heparin | Plasma | Invert 8-10 times |
| Blue | Citrate | Coagulation | Fill to line, invert |
| Yellow | ACD | Cell preservation | Invert 8-10 times |

1. Apply tourniquet (maximum 1 minute)
2. Clean venipuncture site with 70% alcohol
3. Perform venipuncture using appropriate needle gauge
4. Fill tubes in correct order of draw
5. Invert tubes as specified per type
6. Label tubes immediately at bedside

#### 6.2.2 Tissue Collection
1. Receive tissue from surgical/procedure site
2. Document time of removal from body
3. Process according to protocol requirements:
   - **Fresh**: Place in appropriate medium immediately
   - **Frozen**: Snap-freeze in liquid nitrogen or place in -80°C within 30 minutes
   - **Fixed**: Place in 10% neutral buffered formalin (10:1 ratio)
4. Record ischemia time (warm and cold)

#### 6.2.3 Body Fluid Collection
1. Use sterile technique throughout
2. Collect into appropriate sterile container
3. Record volume collected
4. Transport to lab immediately or process per protocol

### 6.3 Specimen Labeling

**Required Label Information:**
- [ ] Unique specimen identifier (barcode)
- [ ] Patient/donor identifier
- [ ] Collection date and time
- [ ] Specimen type
- [ ] Collector initials

**Labeling Requirements:**
- Label at point of collection
- Use approved labels only
- Never pre-label containers with patient info before collection
- Verify label against patient ID band

### 6.4 Initial Processing

1. **Time-Critical Processing**
   - Process within stability window for specimen type
   - Document processing time
   - Note any delays and reason

2. **Centrifugation (if required)**
   | Specimen | Speed | Time | Temperature |
   |----------|-------|------|-------------|
   | Serum | 1500-2000 x g | 10-15 min | Room temp |
   | Plasma (EDTA) | 1500-2000 x g | 10-15 min | 4°C preferred |
   | Plasma (citrate) | 2500 x g | 15 min | Room temp |

3. **Aliquoting**
   - Use sterile technique
   - Aliquot into pre-labeled cryovials
   - Record number and volume of aliquots
   - Avoid multiple freeze-thaw cycles

### 6.5 Storage and Transport

1. **Immediate Storage**
   | Specimen Type | Storage Condition | Maximum Duration |
   |---------------|-------------------|------------------|
   | Fresh tissue | 4°C | 24 hours |
   | Fixed tissue | Room temp in formalin | 72 hours |
   | Frozen specimens | -80°C or LN2 | Long-term |
   | Blood tubes | Per tube type | See stability chart |

2. **Transport Requirements**
   - Use validated shipping containers
   - Include temperature monitors
   - Complete chain of custody documentation
   - Verify receiving facility readiness

## 7. Quality Control

### 7.1 Collection Quality Metrics
| Metric | Target | Frequency |
|--------|--------|-----------|
| Hemolysis rate | <2% | Monthly |
| Labeling errors | 0 | Continuous |
| Ischemia time compliance | >95% | Monthly |
| Consent verification | 100% | Continuous |

### 7.2 Deviation Handling
- Document any deviation from SOP
- Report to Biobank Coordinator immediately
- Complete FRM-BIO-003 Deviation Report
- Quarantine affected specimens pending review

## 8. Documentation

Required documentation for each collection:
- FRM-BIO-001 Specimen Collection Log
- FRM-BIO-002 Chain of Custody Form
- Consent verification record
- Any deviation reports

## 9. Safety Considerations

- Treat all specimens as potentially infectious
- Use appropriate PPE for specimen type
- Dispose of sharps in approved containers
- Follow exposure control procedures
- Report all exposures immediately

## 10. References

- ISBER Best Practices for Repositories (4th Edition)
- CAP Biorepository Accreditation Checklist
- NCI Best Practices for Biospecimen Resources
- Institutional IRB policies

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## Revision History

| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |